Device for performing at least one medical function

ABSTRACT

A device for performing at least one medical function on a user is proposed. The device has at least one medical functional element that is designed to perform the medical function. The medical function is selected from a diagnostic, a therapeutic and a surgical function. The device has at least one evaluation and control part that comprises at least one actuation component for controlling the medical function. The evaluation and control part has at least one casing and at least one battery receptacle. The battery receptacle comprises at least one electrical energy reservoir, more particularly at least one battery. The battery receptacle is designed to be opened irreversibly by the user for removing the energy reservoir.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit and priority of European PatentApplication No. 10 174 253.4, filed Aug. 27, 2010. The entire disclosureof the above application is incorporated herein by reference.

BACKGROUND

The invention relates to a device for performing at least one medicalfunction on a user. Furthermore, the invention relates to a method fordisposing of components of an actuation and evaluation part of a deviceaccording to the invention, more particularly a disposable of theactuation and evaluation part. Devices according to the invention forperforming at least one medical function are used, in particular, in thefield of medical diagnostics or therapeutics. Thus, the device can forexample be embodied as a sensor device for registering at least onebodily function of the user. By way of example, the device can beembodied as a sensor device for qualitative and/or quantitativedetection of at least one analyte in a bodily fluid of the user.However, alternatively, or in addition thereto, the device can also beembodied as, for example, a medication device for administering at leastone medicament to the user. A particular emphasis in the application ofthe present invention lies in continuous or discontinuous long-termmonitoring of at least one analyte concentration in at least one bodilyfluid such as, for example, interstitial fluid or blood. By way ofexample, glucose, cholesterol, lactate, general metabolites or othertypes of analytes or analyte combinations can be considered as analytesto be monitored. In principle, the present invention can also be appliedto other medical fields, for example to diagnostics, therapeutics orsurgery.

The prior art has disclosed a number of medical devices with diagnostic,therapeutic or surgical functions. In particular, monitoring and/orinfluencing certain bodily functions, more particularly monitoring oneor more concentrations of specific analytes, plays a substantial role inthe prevention and treatment of various diseases. Without restrictingfurther possible applications, the invention is substantially describedbelow with reference to blood-glucose monitoring, in particular withreference to continuous long-term blood-glucose monitoring over a numberof hours, days, weeks or even months. However, in principle theinvention can also be applied to other types of analyte monitoringand/or the monitoring of different types of bodily functions and toother fields in medicine. In particular, the invention can also beapplied to medical therapeutics, for example to medication pumps such asinsulin pumps.

Continuous measurements are also becoming ever more established inaddition to so-called point measurements of one or more analytes, inwhich a sample of a bodily fluid is taken from a user in a targetedfashion. Thus, for example, a continuous glucose measurement in theinterstitium (also referred to as continuous monitoring [CM]) has beenestablished in the recent past as an important method for managing,monitoring and controlling a diabetes state, for example. Initially,this continuous monitoring is generally restricted to type I diabetics,i.e. diabetics who usually also wear an insulin pump. By now, use isgenerally made of directly implanted electrochemical sensors, which areoften also referred to as needle-type sensors (NTS). Here, the activesensor region is brought directly to the measurement location, which isgenerally arranged in the interstitial tissue and converts glucose intoelectric charges, for example by using an enzyme (e.g. glucose oxidase,GOD), which charges are proportional to the glucose concentration andcan be used as a measurement variable. Examples of such transcutaneousmeasurement systems are described in U.S. Pat. No. 6,360,888 B1 or in US2008/0242962 A1.

Hence, current continuous monitoring systems are usually transcutaneoussystems. In general, this means that the actual sensor is arranged belowthe skin of the user. However, an evaluation and control part of thesystem, which is also referred to as a patch, is generally situatedoutside of the body of the user, i.e. outside of the human or animalbody. In the process, the sensor is generally applied by means ofinsertion instruments and inserted into the body tissue, which islikewise described in U.S. Pat. No. 6,360,888 B1 in an exemplaryfashion. Other types of insertion instruments have also been disclosed.In general, a sensor is worn for a period of approximately one week;however, longer periods of wear, for example up to one or more months,are also possible. Thereafter, the sensitivity of the sensor generallydrops off as a result of influences such as, for example, enzymes beingused up and/or the sensor becoming encapsulated in the body, and hencethe sensor can be expected to fail. Increasing the length of the periodof wear is an area of active research. However, this means that thesensor, and optionally components such as an insertion needle directlyconnected thereto, should be embodied as replaceable elements.Accordingly, the sensor and, in general, further replaceable componentsof the device constitute a so-called disposable. However, the evaluationand control part of the system, or important, expensive parts thereof(such as e.g. high-resistance amplifier input stages and similar activeelements), are generally reused, and so the device often comprises atleast one reusable.

In the case of implantable sensors, the disposable generally comprises aso-called body mount, which can be affixed to the skin surface of theuser, for example by means of a plaster, and by means of which thesensor that is inserted into the body tissue can be connected or isconnected. The reusable, which contains the essential parts of actuationand/or evaluation electronics for measuring the analyte concentration,is then connected to this body mount. However, components can bearranged in the body mount itself. Thus, for example, at least onebattery can be arranged in the body mount, and so when a body mount isreplaced, and a new body mount and the reusable are assembled, thedevice is at the same time also equipped with a new source of energy.

The effect of this separation between disposable and reusable is thatthe user is not forced to replace or recharge the batteries while thesensor is used because the batteries must be replaced in any case whenthe body mount with the integrated battery compartment is replaced.However, according to relatively recent environmental guidelines, thebatteries have to be able to be disposed of separately by the customerin the case of electrical devices that are powered by batteries. Hence,there is a challenge in developing a device that can be worn on the bodyof the user for a number of days in particular and hence is shieldedfrom all acting environmental influences (damp, temperature variations,mechanical influence), wherein, however, it should at the same time beensured that users can dispose of the batteries themselves after theperiod of wear.

The prior art has disclosed fundamentally different casings for medicaldevices, which either have completely welded-in batteries or havebattery compartments that can be opened and closed a number of times. Byway of example, US 2009/0253960 A1 describes an antenna unit with anantenna for receiving in-vivo information relating to a user. In theprocess, use is made of a cast-in antenna. In the process, flexiblebatteries are proposed inter alia, wherein the advantages of theflexible deformation of the cast-in battery on the body of the user arehighlighted. However, separate disposal of the battery after the servicelife of the medical system is not possible or only possible with greatdifficulties.

Furthermore, the prior art has disclosed systems in which the batterycan be replaced. By way of example, U.S. Pat. Nos. 6,498,951, 6,749,587and 6,175,752 B1 illustrate various systems in which batteries can bereplaced. To this end, U.S. Pat. No. 6,749,587 describes a batterycompartment with a lid. U.S. Pat. Nos. 6,498,951 and 6,175,752 describecasings with two components, which can be detachably interconnected andin which provision is made for a hermetic seal of the batterycompartment.

However, both known approaches have disadvantages because theabove-described technical challenges are not overcome completely. Thus,in the one case, the battery cannot be disposed of separately and, inthe other case, the replaceable embodiment of the battery and thetechnical requirements connected thereto, which relate to the batterycompartment, represent significant technical challenges. In particular,in the case of battery compartments that should be opened reversibly,moisture-tightness must still be ensured because very high requirementsare to be set in this respect, particularly in the case of medicaldevices that can be worn on the body of a user.

SUMMARY

Accordingly, it is an object of the present invention to provide adevice for performing at least one medical function on a user, whichdevice avoids the disadvantages of known devices of the aforementionedtype. More particularly, firstly, a user should not be forced to replaceor recharge batteries during use and, secondly, separate disposal of thebatteries should be possible after use.

A device for performing at least one medical function on a user isproposed. Here, a medical function should be understood to mean adiagnostic, a therapeutic or a surgical function. A combination ofvarious functions is also possible. In particular, the device can beembodied as a compact instrument that can be carried along by the user.More particularly, the device can be embodied as a compact instrumentthat can wholly or partly be worn on or in the body of the user.

The device has at least one medical functional element that is designedto perform the at least one medical function. The medical functionalelement is accordingly matched to the at least one medical function. Byway of example, as explained above, the medical function can comprise atleast one diagnostic function such that the medical functional elementcan for example be wholly or partly embodied as a diagnosis element, forexample by it comprising at least one sensor for registering at leastone bodily function. In principle, this may be any bodily functions.More particularly, the sensor can be at least one sensor forquantitative and/or qualitative detection of at least one analyte in atleast one bodily fluid, for example one or more of the above-describedsensors, more particularly a sensor for registering a blood-glucoseconcentration in a bodily fluid. By way of example, if the medicalfunction comprises a therapeutic function, the medical functionalelement can for example comprise at least one therapeutic actuator thatcan be designed to act on at least one bodily function of the userand/or exert a stimulus on the body of the user. By way of example, thisactuator can comprise at least one medication device; for example, atleast one insulin pump. Alternatively, or in addition to theaforementioned medical functions and/or the aforementioned medicalfunctional elements, the device can however also comprise other and/orfurther medical functions and/or medical functional elements.

In the following text, the invention is substantially described withreference to a preferred exemplary embodiment, in which the device is adevice for qualitative and/or quantitative detection of an analyte in abodily fluid, with a casing that can be applied to the skin surface ofthe user and a sensor that can be inserted into body tissue of the user.With the exception of the embodiment according to the invention,reference can be made to the above description of known sensors, moreparticularly known long-term sensors, for examples of such devices.However, in general the medical function can be selected from adiagnostic function, a therapeutic function and a surgical function, orfrom combinations of the aforementioned functions.

The device has at least one evaluation and control part. Moreparticularly, this evaluation and control part can wholly or partly beembodied as a so-called patch, which is worn directly or indirectly onthe skin surface of the user, for example with at least one plasterbeing placed therebetween. Here, within the scope of the presentinvention, an evaluation and control part should be understood to meanan integral component or else a component with a multi-part design thatis designed to apply at least one signal, for example an electricalsignal, and/or at least one form of energy, for example a current and/ora voltage, to the medical functional element and/or to prompt themedical functional element by other means to perform its medicalfunction, and/or that is designed to record at least one electricalsignal from the medical functional element, e.g. a voltage signal and/ora current signal. By way of example, recorded signals can easily beregistered and/or wholly or partly converted and/or stored and/oralready be evaluated or processed, at least in part. In the case of asensor element as a medical functional element, the evaluation andactuation part can for example be designed to apply a voltage and/or acurrent to the sensor element, and/or it can for example comprise ameasurement-value amplifier and/or a potentiostat in order to recordvoltage or current signals. In the case of a medication device as amedical functional element, the evaluation and actuation part can forexample also comprise one or more fluidic, mechanical orfluid-mechanical components, for example a pump, a valve, a pipe systemor combinations of the aforementioned and/or other elements. Variousembodiments are possible.

The evaluation and actuation part can have an integral or else amulti-part design. Both options should be possible according to theinvention. Without restricting other embodiments, the invention will bedescribed below substantially with reference to multi-part embodimentsof the evaluation and actuation part. Hence, the evaluation andactuation part can in particular have at least one disposable and atleast one reusable. Here, a disposable is understood to mean a part ofthe device, more particularly of the evaluation and actuation part, thatis only used once or a few times when used as intended, whereas thereusable can be used a number of times when used as intended, forexample at least 5 times, at least 10 times or even at least 50 times,for example up to 500 times or more.

The disposable and the reusable can preferably be interconnected in areversible fashion. In the case of this connection, the evaluation andactuation part, or a part thereof, can in particular be formed as aunit, which is also referred to as a patch below. The evaluation andactuation part, preferably with the disposable and the reusable, can forexample be attachable to the skin surface of the user, wherein, forexample, the medical functional element and/or part thereof can alsoproject into the body tissue, for example by means of an insertion. Theconnection between disposable and reusable is preferably embodied in areversible fashion. By way of example, the connection may be a force-fitand/or interlocking connection. To this end, the disposable and/or thereusable can for example each comprise one or more connection elements.By way of example, provision can be made for a plug-in connection bymeans of which the disposable and the reusable can be plugged togetherto form the unit. A unit that comprises a plurality of disposablesand/or a plurality of reusables can also be implemented. The unit, madeof disposable and reusable in a connected state, can more particularlyhave a substantially moisture-tight embodiment, for example to shield aninterior of this unit from moisture.

The evaluation and actuation part, more particularly the reusable, hasat least one actuation component for controlling the medical function.By way of example, the evaluation and actuation part can have at leastone casing. More particularly, the reusable can have at least onereusable casing. The at least one actuation component can be arranged inthe interior of the at least one casing, for example in the interior ofthe reusable casing. This at least one actuation component can forexample comprise at least one active electronic component, for exampleat least one operational amplifier and/or similar electronic components.Furthermore, the actuation component can for example also comprise atleast one integrated circuit. Here, an actuation component should beunderstood to mean a component in general, which is designed to actuateand/or register the medical function of the medical functional element,for example by applying at least one electrical current, at least oneelectrical voltage or another type of stimulus to the medical functionalelement and/or by registering at least one signal, which is generated bythe medical functional element, and for example converting and/orstoring it. Alternatively, or in addition thereto, the at least oneactuation component can also comprise at least one mechanical,electromechanical or fluidic component for supporting and/or controllingthe medical function, for example at least one pump, at least one pipesystem or at least one valve. Various other embodiments are possibleand, in principle, known from the prior art.

The evaluation and control part has at least one casing and at least onebattery receptacle. By way of example, the disposable can have at leastone disposable casing and/or the reusable can have at least one reusablecasing, wherein, optionally, the disposable casing and the reusablecasing can complement each other, preferably in a fluid-tight, airtightor vapor-tight fashion, to form the casing of the evaluation and controlpart or part of the same when the disposable is connected to thereusable. Here, within the scope of the present invention, a casingshould generally be understood to mean a mechanical component thatsubstantially determines the shape of a part completed by the casing,e.g. the evaluation and control part and/or the disposable, to theoutside and protects and/or shields the part from e.g. mechanical and/orchemical influences. By way of example, the disposable casing cancomprise the at least one connection element that can be used to connectthe disposable to the reusable, for example one or more plug-inconnectors and/or latching connectors and/or other connection elements.Alternatively, or in addition thereto, the optional disposable and theoptional reusable can also be connected differently than over theircasings, for example over plug-in connectors or other connectors, whichare not necessarily part of the casing, or connected in another fashion.The disposable casing can in particular form a unit together with thereusable, for example by embodying the disposable casing and thereusable casing in a complementary fashion.

The battery receptacle can be embodied as a component of the casing,more particularly the disposable casing, or merely be connected to thecasing, more particularly the disposable casing. Here, a batteryreceptacle should be understood to mean an element that is designed tohold at least one electrical energy reservoir. In the device, thebattery receptacle has at least one such electrical energy reservoir. Byway of example, this at least one electrical energy reservoir cancomprise at least one battery. However, in principle other types ofelectrical energy reservoirs can also be used, independently of the termbattery receptacle. By way of example, the battery receptacle can haveat least one interior, for example an interior that holds the electricalenergy reservoir and is hermetically sealed to the outside by thebattery receptacle. By way of example, the interior can be shielded in amoisture-tight and/or airtight and/or water-vapor-tight fashion from thesurroundings.

According to the invention, it is proposed that the battery receptacleis embodied such that it can be opened irreversibly by the user forremoving the energy reservoir. In particular, this opening should beable to be brought about without the use of tools, for example by hand.Here, irreversible opening should be understood to mean opening duringwhich the battery receptacle is deformed by the user such that a returnto an original state is not possible, at least without using tools, aidsor other auxiliary means. In particular, during the opening, ahermetically shielded interior of the battery receptacle can beirreversibly opened with respect to the surroundings such that renewedclosing of the interior, during which the hermetic shield and/or seal isreinstated, cannot be achieved without aids such as e.g. adhesives,tools or the like.

In particular, the battery receptacle can comprise at least one closureelement that should be opened in an irreversible fashion, moreparticularly a closure element that should be opened by the user, moreparticularly at least one sealing film, for example at least one sealingfilm that has been adhesively bonded and/or welded to abattery-receptacle casing of the battery receptacle. By way of example,this sealing film can hermetically seal the above-described optionalinterior of the battery receptacle with respect to its surroundings. Byway of example, the user can open the closure element. By way ofexample, a manual action can open said element. Thus, the user can forexample manually pull off the sealing film. Alternatively, or inaddition thereto, the closure element can also be opened by automatic orsemi-automatic means, for example coupled to at least one other useraction. By way of example, if, as will be explained in more detailbelow, the casing comprises a battery-receptacle casing that can bedetached from the casing, the closure element can for example bedesigned such that it is automatically opened when thebattery-receptacle casing is detached from the casing, for example byautomatically removing a sealing film. In another alternative, or inaddition to the above, the closure element can for example also beopened by separating the disposable and the reusable and/or thisseparation may initiate the opening. By way of example, if a disposableis separated from the reusable, for example on the body surface or in astate separated from the body surface, this separation can moreparticularly also lead to the closure element being opened, for exampleto the sealing film being opened.

In particular, as described above, the battery receptacle may have atleast one battery-receptacle casing. This battery-receptacle casing andthe casing, more particularly the disposable casing, can beinterconnected, for example by force-fit and/or interlocking connection.This connection between the battery-receptacle casing and the casing,more particularly the disposable casing, can more particularly beembodied such that it can be detached, more particularly detached in anirreversible fashion, by the user, for example under the action ofcustomary manual forces of the user. In particular, this can be broughtabout by virtue of the fact that the battery-receptacle casing and/orthe casing, more particularly the disposable casing, are deformed whenthe connection is detached, which more particularly can once again beperformed manually and without the aid of tools, such thatre-establishing the connection is prevented. More particularly, this canbe brought about by virtue of the fact that when the battery-receptaclecasing and/or the casing, more particularly the disposable casing, areseparated, the battery-receptacle casing and/or the casing is kinkedand/or ripped, and this prevents the connection from beingre-established. More particularly, the casing, preferably the disposablecasing, can have at least one predetermined breaking point, wherein thecasing is deformed when the battery-receptacle casing is detached fromthe casing, more particularly the disposable casing, more particularlyin an irreversible fashion, such that further use preferably is nolonger possible. By way of example, this can be brought about by virtueof the fact that the predetermined breaking point comprises at least oneweakening in the casing, more particularly in the disposable casing.More particularly, the predetermined breaking point can be embodied suchthat said predetermined breaking point has to be deformed, for examplekinked, such that the battery-receptacle casing can be detached from thecasing, more particularly the disposable casing. In general, the casing,more particularly the disposable casing, can be embodied such that thecasing is broken and/or kinked during the deformation.

The casing, more particularly the disposable casing, can in particularcomprise at least one base plate. Here, in general, a base plate shouldbe understood to mean a possibly, but not necessarily, plate-shapedelement that has or provides an assembly platform for the actuation andevaluation part, more particularly for the disposable. By way ofexample, the base plate can comprise at least one planar surface facingaway from the skin surface of the user, on which surface the optionaldisposable can be configured and on which the optional reusable canpreferably also be assembled. In particular, this base plate can have atleast one receptacle region for holding the battery-receptacle casing.More particularly, this receptacle region can be arranged on a surfaceof the base plate facing away from the skin surface of the user. Asillustrated above, the receptacle region can more particularly beembodied such that the battery-receptacle casing can only be detachedfrom the receptacle region after the base plate has been deformed,preferably in an irreversible fashion, for example along a predeterminedbreaking point, more particularly a kink line. By way of example, thebattery-receptacle casing can be connected to the base plate in thereceptacle region by means of a force-fit and/or interlocking connectionwhen the actuation and evaluation part, more particularly thedisposable, is in the operational state. Kinking and/or another type ofirreversible deformation of the base plate can, preferably in anirreversible fashion, make this force-fit and/or interlockingconnection, which may comprise e.g. a latching connection, detachable.By way of example, the base plate may be able to kink along at least onekink line, wherein the battery-receptacle casing can be detached fromthe base plate as a result of kinking, for example by uncovering aforce-fit and/or interlocking connection between the battery-receptaclecasing and the base plate. Preferably there is such a deformation of thebase plate that it is no longer possible to use it.

By way of example, this can in turn be brought about by using at leastone predetermined breaking point, for example the aforementioned kinkline.

In particular, as explained above, the battery-receptacle casing cancomprise at least one closure element. By way of example, this closureelement can comprise at least one sealing film. More particularly, theclosure element can be embodied such that it can only be opened for theuser for removing the energy reservoir from the battery receptacle oncethe battery-receptacle casing has been detached from the disposablecasing. More particularly, the battery receptacle can be embodied to beinaccessible to the user during the operation of the device, i.e. whenthe battery-receptacle casing is connected to the disposable. Theclosure element can in particular be embodied such that it can only beopened, by the user in particular, once the battery-receptacle casinghas been detached from the casing, more particularly the disposablecasing. By way of example, this can be brought about by virtue of thefact that the closure element is arranged on a side of thebattery-receptacle casing facing the casing, more particularly thedisposable casing. Hence the closure element is only uncovered once thebattery-receptacle casing is detached from the casing. In the process,the battery-receptacle casing can be detached wholly, or else partly,from the casing, more particularly the disposable casing, wherein apartial detachment can for example comprise a pivoting-open of thebattery-receptacle casing, a swinging-open or the like. However, it isparticularly preferred if the battery-receptacle casing can be removedcompletely from the casing, more particularly the disposable casing. Asdescribed above, the casing, more particularly the disposable casing,can for example have at least one base plate with at least onereceptacle region for holding the battery-receptacle casing. When thebattery-receptacle casing is held in the receptacle region, there canfor example be an interlocking and/or force-fit connection to the baseplate, which can for example be detachable by kinking and/or breakingalong a predetermined breaking point, for example a kink line. Thebattery-receptacle casing for example can be uncovered and can beseparable from the casing, more particularly the disposable casing, onlyafter this breaking and/or kinking, such that the closure element can beopened by a user, preferably in a purely manual fashion again.

The device can be able to be affixed, more particularly wholly orpartly, onto the skin surface of the user by means of an attachmentelement, preferably by means of at least one plaster and/or another typeof self-adhesive surface. More particularly, as described above, theactuation and evaluation part, more particularly the disposable, cancomprise at least one such attachment element, for example at least onesuch self-adhesive surface and/or at least one such plaster. By way ofexample, the actuation and evaluation part, more particularly thedisposable, can, as described above, have at least one base plate with asupport surface, which faces the skin surface of the user and can eitherhave a self-adhesive embodiment or be fixable on the skin surface bymeans of at least one adhesive element. By way of example, the optionalreusable can then, directly or indirectly, be placed onto or against thebase plate of the casing of the actuation and evaluation part, moreparticularly the base plate of the disposable casing of the disposable,and can be connected to the optional disposable. Accordingly, the devicecan for example be embodied wholly or partly as a so-called patch, whichcan for example be stuck onto the skin surface. Protruding from theactuation and evaluation part, more particularly the unit made ofdisposable and reusable, a sensor and/or a cannula, for example, canwholly or partly extend into the body tissue of the user, i.e. throughthe skin of the user and into the body tissue.

In particular, the optional disposable can be embodied such that it doesnot comprise any electronic components itself. Here, the battery or theelectrical energy reservoir and optionally present contact elementsand/or conductors should not count as electrical components. Inparticular, passive electrical components such as e.g. electricalresistors and/or diodes and active electrical components such as e.g.operational amplifiers and/or circuits, more particularly ASICs, shouldcount as electrical components, and these should preferably not becontained in the disposable.

As illustrated above, the functional element can perform at least onemedical function. More particularly, the functional element can beselected from: a sensor for registering at least one body state of theuser, more particularly a sensor for qualitative and/or quantitativeregistering of at least one analyte in a bodily fluid, more particularlya sensor that can be inserted into body tissue of the user; an actuatorfor influencing at least one body state of the user, more particularly afluidic actuator for carrying out at least one medication function,preferably an actuator with at least one actuator part, preferably atleast one cannula, that can be inserted into body tissue of the user.Various other embodiments or combinations of the aforementioned and/orother embodiments of the functional element are possible. Thus, thefunctional element can more particularly comprise at least one part thatcan be inserted into the body tissue, such as e.g. at least one sensorand/or at least one cannula.

The functional element can more particularly be connectable to theactuation and evaluation part, for example to the disposable, and/or canbe part of the actuation and evaluation part, for example thedisposable. The connection can have a reversible or else irreversibleembodiment.

As described above, the reusable and the disposable can in a connectedstate form a common unit of the device. In the process, a common casingin particular can be created, which forms the casing of the actuationand evaluation part or a part thereof. This common casing can, inparticular, have a substantially moisture-tight and/or vapor-tightdesign, more particularly in order to protect components present in thereusable and/or the disposable against moisture and/or in order toprotect other components of the actuation and evaluation device and/orthe electrical energy reservoir against moisture. Connection elementsbetween the reusable and the disposable can also be shielded in amoisture-tight fashion, for example by using appropriate sealingelements such as O-rings. By way of example, this can, in amoisture-tight fashion, shield a plug-in connection between the reusableand the disposable, which connection can also comprise an electricalplug-in connection in addition to a purely mechanical plug-in function.

In addition to the above-described device in one or more of theabove-described embodiments, a method is furthermore proposed fordisposing of components of an actuation and evaluation part, moreparticularly a disposable, of a device according to the invention in oneor more of the above-described embodiments. If the actuation andevaluation part contains at least one disposable and at least onereusable, then a connection between the disposable and the reusable, inparticular, can be separated by this method. Furthermore, a batteryreceptacle is irreversibly opened in the method for removing the energyreservoir and the energy reservoir is removed from the batteryreceptacle. The at least one energy reservoir can subsequently bedisposed of separately to the remaining components of the actuation andevaluation part, more particularly the disposable. In the method, abattery-receptacle casing of the battery receptacle in particular can beirreversibly separated from a casing of the actuation and evaluationdevice, more particularly a disposable casing of the disposable, moreparticularly by deforming at least one predetermined breaking point. Thebattery receptacle can subsequently be opened irreversibly to remove theenergy reservoir.

The proposed device and the proposed method have a number of advantagesover known devices and methods. In particular, the device can forexample be embodied as a continuous monitoring sensor for glucose, whichcan be worn on the body of the user for a number of days, weeks or evenmonths, during which time the glucose sensor can be implanted into thebody tissue of the user. The sensor can generate an electrical current,which can be converted into a voltage that is proportional to theglucose measurement value. A wireless connection in particular can beprovided for amplifying and outputting the measurement value, forexample by means of at least one wireless component contained in theactuation and evaluation part, for example the reusable. The electricalenergy required for this can be provided by the at least one electricalenergy reservoir contained in the actuation and evaluation part, moreparticularly the disposable, for example over an electrical connection,more particularly an electrical plug-in connection, for example betweenthe disposable and the reusable. For functional security and in order tomaintain the quality of life of the user, the complete device can,whilst in operation, withstand all active environmental influences, suchas damp, temperature variations, mechanical influences or similarinfluences.

The proposed option for disposal prevents the user from having torecharge the electrical energy reservoir, which would require a separaterecharger. Furthermore, the long-term measurement, which typically lasts7 days or more, does not in general have to be interrupted, for examplebecause a rechargeable battery was not fully charged at the outset. Byway of example, users themselves can undertake the above-describeddisposal procedure. Returning the device to the producer when thebattery is empty, in exchange for a new device, is no longer necessary.This also avoids the situation where a producer or a separate disposalcompany receives contaminated devices, which have to be decontaminatedand then laboriously refurbished.

The device can in particular be embodied as a body mount or comprise abody mount, i.e. a component that is designed to be affixed to the skinof the user. In particular, the body mount can comprise the base plateand the battery receptacle. By way of example, one or more batteries canbe situated in the body mount, which batteries are housed in a batteryreceptacle in, for example, a disposable, which battery receptacle canbe destroyed when the batteries are removed. By way of example, after ameasurement, for example after 7 days of measuring, the user can openthe original seal and remove the batteries and dispose of theseseparately. The rest of the body mount can be disposed of in domesticrefuse.

Hence, the proposed device can be used to ensure that the user alwayshas fresh batteries available for supplying the device, for examplebefore a measurement. By way of example, this can prevent a measurementby means of the device failing because the battery voltage is too low;in the case of relatively long usage, for example 7 days of measurementor more, this constitutes a significant advantage.

The device, more particularly the common casing, which is moreparticularly embodied as a body mount, can in particular provide ahermetically sealed assembly. The optional disposable can form a bodymount or a part thereof, which itself can be checked separately, forexample independently of the reusable. In general, there is no longer aneed to return contaminated assemblies to the producer. Nor is aseparate charger required for the device or the electrical energyreservoir contained in this device. The user him/herself does not haveto intervene in the preferably hermetically sealed system. Since theuser him/herself does not insert the battery into the batteryreceptacle, the risk of inserting said battery with poles reversed isdispensed with. Since the user destroys the battery receptaclepreferably completely and more particularly visibly during the batteryremoval, the reusable and more particularly the battery receptacle ofthe reusable can preferably never be used again. This also reduces therisk of infection.

The embodiment of the actuation and evaluation part in particular, forexample the embodiment of the disposable, with at least onepredetermined breaking point, for example in a base plate, moreparticularly a base plate of the body mount, is particularly preferredbecause it is particularly simple for the user to kink such apredetermined breaking point. This kink can make e.g. a batteryreceptacle, more particularly a battery compartment, accessible in orderto dispose of batteries and/or other types of energy reservoirs.Furthermore, the actuation and evaluation part, and more particularlythe disposable thereof, for example the body mount, can be changed inthis manner geometrically such that further use of the body mount isrendered impossible. Thus, provision can more particularly be made for ahermetically sealed battery receptacle that is inaccessible to the userand that, at the end of its service life, can easily be broken openand/or opened irreversibly in another fashion by the user.

DRAWINGS

Further details and features of the invention emerge from the followingdescription of preferred exemplary embodiments, which are illustratedschematically in the figures. Here, identical reference signs in theindividual figures denote identical or functionally identical elements,or elements with corresponding functions. The invention is notrestricted to the exemplary embodiments.

FIG. 1 shows an exemplary embodiment of a device according to theinvention with a disposable and a reusable; and

FIGS. 2A to 2C show various method steps of a method for disposing ofcomponents of the disposable of the device as per FIG. 1.

DETAILED DESCRIPTION

The following description of technology is merely exemplary in nature ofthe subject matter, manufacture and use of one or more inventions, andis not intended to limit the scope, application, or uses of any specificinvention claimed in this application or in such other applications asmay be filed claiming priority to this application, or patents issuingtherefrom.

FIG. 1 illustrates a perspective illustration of an exemplary embodimentof a device 110 according to the invention for performing at least onemedical function on a user. In the illustrated exemplary embodiment, thedevice 110 is embodied as a sensor device for long-term monitoring of ananalyte in a bodily fluid, for example for glucose monitoring, and has amedical functional element 114 in the form of a sensor, which can forexample be embodied as an electrochemical sensor and which can beinserted into body tissue of the user through the skin surface of theuser. The sensor is connected to a casing 118, which can be attached tothe skin surface of the user, of an evaluation and control part 120,which is also referred to as a patch. This patch 120 has a self-adhesivesurface 122, which faces the skin surface, of a plaster 124.

In the illustrated exemplary embodiment, the patch 120 optionally has amulti-part design and, in the illustrated exemplary embodiment,comprises a reusable 126 and a disposable 128, of which the plaster 124is also a part. However, this multi-part design is not mandatory, and sothe illustrated example could also be modified such that the actuationand evaluation part 120 has an integral design. The disposable 128comprises a base plate 130, which is connected to the plaster 124 andbears the reusable 126. Furthermore, a battery-receptacle casing 132 ofa battery receptacle 134 is applied to the base plate 130. While thereusable 126 contains actuation and evaluation electronics 136 (notillustrated in any more detail in FIG. 1), at least one electricalenergy reservoir 138 in the form of e.g. at least one battery 140(likewise not illustrated in any more detail in FIG. 1) is held in thebattery receptacle 134. The reusable 126 is reversibly connected to thedisposable 128, for example over one or more connection elements 142,which can for example be identified in the separate illustration of thedisposable 128 in FIG. 2A. By way of example, this can establish ahermetically sealed plug-in connection, which is embodied such that itcan be detached, between the disposable 128 and the reusable 126, and sothe patch 120 is created as a common unit.

As described above, a challenge in the case of devices 110 such as thedevice illustrated in FIG. 1 in particular consists of not having toforce the user to either replace or recharge the batteries 140 while thedevice 110 is in use because the battery receptacle 134 is stuck ontothe skin surface of the patient together with the base plate 130 duringuse. Secondly, despite the sealed battery receptacle 134, it should beensured that the user can dispose of the batteries 140 separately afterthe period of wear.

This is ensured by a special embodiment of the disposable 128, which canbe identified in FIGS. 2A to 2C. FIG. 2A shows that the base plate 130of the disposable 128 comprises a predetermined breaking point 144 inthe form of a kink line 146. After the application, for example ameasurement duration of 7 days, the user can pull the disposable 128,which is also referred to as a body mount, off the skin surface togetherwith the plaster 124 and kink the base plate 130 along the predeterminedbreaking point 144 to the extent that the battery receptacle 134, forexample a separable battery compartment, detaches from the base plate130. Up until this point the battery receptacle 134 with itsbattery-receptacle casing 132 can be connected to a disposable casing150, for example the base plate 130, by an interlocking and/or force-fitconnection over e.g. one or more connection elements 148, with thisconnection being detached irreversibly during the kinking. Asillustrated in FIG. 2B, the battery-receptacle casing 132 of the batteryreceptacle 134 can then be completely detached from the base plate 130of the disposable casing 150.

The battery-receptacle casing 132 can have at least one closure element154 on a side of the battery receptacle 134 facing a receptacle region152 of the base plate 130 in the usage state, i.e. in the non-separatedstate, which closure element can preferably be opened in an irreversiblefashion. In particular, this can be a sealing film 156 adhesively bondedand/or welded to the battery-receptacle casing 132, which film can havea transparent or else opaque embodiment and can be produced, forexample, from a plastic material and/or a metallic material and/or alaminate material. By pulling off this sealing film 156, as illustratedin FIG. 2C, the battery 140 can be removed from the battery receptacle134 or the interior 158 thereof, which preferably was previouslyhermetically sealed by the sealing film 156. This allows a separatedisposal of the batteries 140, which is independent of the disposal ofthe remainder of the disposable 128.

FIGS. 2B and 2C once again allow identification of details of theconnection elements 148. Thus, it is possible to identify that theseconnection elements can firstly comprise a latching connection 160 andsecondly for example also a plug-in connection 162 in addition theretoor as an alternative thereto. However, in principle, other embodimentsare also possible. By kinking the predetermined breaking point 144 alongthe kink line 146, the base plate 130 loses its rigid shape such thatthe latching connection 160 would not re-latch even if the plug-inconnection 162 were re-established, and so the separation of the batteryreceptacle 134 from the base plate 130 is irreversible.

LIST OF REFERENCE NUMERALS

-   110 Device for performing at least one medical function-   112 Sensor device-   114 Medical functional element-   116 Sensor-   118 Casing-   120 Evaluation and control part (patch)-   122 Self-adhesive surface-   124 Plaster-   126 Reusable-   128 Disposable-   130 Base plate-   132 Battery-receptacle casing-   134 Battery receptacle-   136 Actuation and evaluation electronics-   138 Electrical energy reservoir-   140 Battery-   142 Connection elements-   144 Predetermined breaking point-   146 Kink line-   148 Connection element-   150 Disposable casing-   152 Receptacle region-   154 Closure element-   156 Sealing film-   158 Interior-   160 Latching connection-   162 Plug-in connection

What is claimed is:
 1. A device for performing at least one medicalfunction on a user, comprising: at least one medical functional elementthat is designed to perform the medical function, wherein the medicalfunction is selected from a diagnostic, a therapeutic and a surgicalfunction; and at least one evaluation and control part, wherein theevaluation and control part has at least one actuation component forcontrolling the medical function, wherein the evaluation and controlpart has at least one casing and at least one battery receptacle thathas a battery-receptacle casing, the casing comprises at least one baseplate, the base plate has at least one receptacle region for holding thebattery-receptacle casing, the base plate can be kinked along at leastone kink line, the battery-receptacle casing can be detached from thebase plate as a result of kinking along the kink line of the base plate,wherein the battery receptacle comprises at least one battery, whereinthe battery receptacle is designed to be opened irreversibly by the userfor removing the battery, wherein the battery-receptacle casing and thecasing are connected and the connection can be detached by the user, andwherein the battery-receptacle casing and/or the casing are/is deformedwhen the connection is detached such that re-establishing the connectionis prevented.
 2. The device according to claim 1, wherein the evaluationand control part has at least one disposable and at least one reusable,wherein the disposable and the reusable can be reversiblyinterconnected, wherein the reusable has the at least one actuationcomponent for controlling the medical function, wherein the disposablehas at least one disposable casing and the at least one batteryreceptacle.
 3. The device according to claim 1, wherein the batteryreceptacle comprises at least one closure element that can be opened inan irreversible fashion.
 4. The device according to claim 1, wherein thecasing is broken and/or kinked during the deformation.
 5. The deviceaccording to claim 1, wherein the connection between the casing and thebattery-receptacle casing is selected from a force-fit and aninterlocking connection.
 6. The device according to claim 1, wherein thebattery-receptacle casing comprises a closure element, wherein theclosure element is embodied such that it can only be opened for the userfor removing the energy reservoir from the battery receptacle once thebattery-receptacle casing has been detached from the casing.
 7. Thedevice according to claim 1, wherein the functional element is selectedfrom: a sensor for registering at least one body state of the user; andan actuator for influencing at least one body state of the user.
 8. Thedevice according to claim 2, wherein the reusable and the disposableform a common casing of the device in a connected state.